NCT05084027招募中2 期
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen Prior to Allogeneic Hematopoietic Stem Cell Transplantation for Older Patients With Hematologic Malignancies
First Affiliated Hospital of Zhejiang University8 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年10月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- disease free survival
研究概览
简要总结
venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for older patients with hematologic malignancies
详细描述
It was a phase Ⅱ clinical trial of new designed reduced-intensity conditioning regimen for older patients accepting allogeneic hematopoietic stem cell transplantation treatment. The regimen consisted of venetoclax combining with fludarabine and melphalan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 50 years
- •Patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome according to WHO diagnostic criteria.
- •Patients who achieved complete remission before transplantation.
- •Patients who have alternative donors and plane to accept allogeneic hematopoietic stem cell transplantation treatment.
- •ECOG body status score 0-
- •Good organ function level: ANC (neutrophil absolute value >=1.0x10^9/L; PLT >=30x10^9/L; HB >=80g/L; Tibil <=1.5 ULN; ALT / AST <=2.5 ULN; bun / Cr <=1.5 ULN; LVEF >=50%).
- •Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing.
排除标准
- •Patients who didn't achieved complete remission before transplantation (bone marrow smear: proportion of primordial cells >=5%) or any extramedullary recurrence.
- •Patients who were previously known to be resistant to venetoclax.
- •In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate the super pretreatment scheme.
- •Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment.
- •In patients with severe renal insufficiency, the renal function index (CR) is more than 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinine clearance rate (CR) is less than 50ml / min, the researchers evaluated that they could not tolerate the super pretreatment scheme.
- •In patients with severe active infection, the researchers evaluated that they could not tolerate the pretreatment.
- •Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study.
- •Other reasons why the researchers could not be selected.
研究组 & 干预措施
treatment group
Experimental
older patients accepting venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation treatment
干预措施: venetoclax combining with fludarabine and melphalan (Combination Product)
结局指标
主要结局
disease free survival
时间窗: 2 year
2-year DFS
次要结局
- overall survival(2 year)
- incidence of toxic reaction(2 year)
- cumulative incidence of relapse(2 year)
- incidence of acute and or chronic graft verus host disease(2 year)
研究者
Yi Luo
Principal Investigator
First Affiliated Hospital of Zhejiang University
研究点 (8)
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